The University of Louisville Clinical and Translational Research Support Center (CTRSC) will be responsible for data collection, data quality, and data analysis for this project. The CTRSC (http://www.ctrsc.net) is a multi--‐disciplinary team comprised of professionals in medicine, public health, statistics, and computer science. The team has considerable experience managing and supporting single--‐site and multi--‐center clinical research studies. Specifically, members of the CTRSC will be responsible for: